MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 12/22/2022, it was reported by a sales representative via email that a patient was burned after an ar-3210-0033 camera head was placed on the patient after a laparoscopic procedure on (b)(6) 2022.The light cord and scope were disconnected, then the camera was placed on the patients skin, that resulted in a burn.No additional information was provided.Additional information requested.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual examination, it was noted that one of the lenses is cloudy and the other is discolored around it.However, the camera cannot be on the patient, per dfu-0327-4, section f- safety information-warning: risk of burns! the cause remains misuse.
Event or Problem Description
On 12/22/2022, it was reported by a sales representative via email that a patient was burned after an ar-3210-0033 camera head was placed on the patient after a laparoscopic procedure on 12/22/2022.The light cord and scope were disconnected, then the camera was placed on the patients skin, that resulted in a burn.No additional information was provided.Additional information requested.Additional information provided 12/23/22: images of the burn are not available.The camera was by itself when placed on the patient that allegedly caused the burn.The scope and light cord were disconnected.Devices will be returned.Additional information received on 1/13/2023: the patient was burn during the procedure while the scope, light cord, and camera were all attached.Then surgeon turned the rooms light on, at the end of the procedure, the burn was noticed.

• Brand Name: 4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16120533
• Report Number: 1220246-2023-06051
• Device Sequence Number: 15079262
• Product Code: GCJ
• UDI-Device Identifier: 00888867346628
• UDI-Public: 00888867346628
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K941541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR
• Device Catalogue Number: AR-3352-5531
• Device Lot Number: 13970726
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown